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  1. Actions & Enforcement

Import Alerts

Import Alerts are used to protect consumers against products with a history of known violations. FDA can place a product on an Import Alert after discovering a violation and then detain future shipments of the product without having to test or otherwise physically examine it. FDA refers to this as “detention without physical exam” or “DWPE”.

If a product subject to DWPE is offered for import, it will be detained and refused unless the importer can overcome the appearance of the violation(s) by demonstrating to the FDA that the product does not have the violation(s) listed on the import alert. The “Guidance” section of each import alert provides more information on what evidence may be appropriate. 

Fast Facts about Import Alerts

FD&C Act Section 801 (21 USC Section 381) of the Federal Food, Drug, & Cosmetic Act gives FDA the authority to refuse products that appear to be in violation of FDA laws and regulations.  This is known as the “appearance standard”.

The FDA issues “Import Alerts” to notify the public, the import community, and FDA staff of the products and firms that appear to be in violation of FDA laws and regulations.

Violations could be related to the product, manufacturer, shipper, importer, Country of origin and/or other information.

Each import alert lists the reason for the alert, what products and firms are affected, what FDA laws and/or regulations appear to have been violated, and other information.

The “Guidance” section provides information on how DWPE is applied, how to secure a release of a shipment, how to be removed from the import alert, and contact information.

Prior to importing into the United States, importers should determine if their products are subject to DWPE, and if so, become familiar with the instructions and possible evidence that will need to be presented to secure a release of the shipment.

 

Search FDA's Import Alerts

Import alert databases are updated in real time.
Enter key word(s), firm name, product, etc. to search import alerts:

 

Click to Subscribe to FDA's Import Alerts Weekly Summary OR Browse all import alerts:
 By Country/Area  
  By Industry  
 By Assigned Number 
 By Last Published Date 

Keep in mind:
If the import alert has a YELLOW OR RED LIST:

  • Firms/products that appear on the YELLOW OR RED LIST of an import alert are SUBJECT to DWPE under that alert.
  • Firms/products that do not appear on the yellow or red list are not subject to DWPE under that alert.

If the import alert has a GREEN LIST:

  • Firms/products that appear on the GREEN LIST of an import alert are EXEMPT from DWPE under that alert. 
  • Firms/products that do not appear on the green list are not exempt from DWPE (i.e., they are subject to DWPE) under that alert.
     

For information on how to be removed from an import alert, please see the import alert removal page.



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